Actively Recruiting

Age: 18Years +
All Genders
NCT05457569

Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization

Led by Centre Hospitalier Universitaire Dijon · Updated on 2024-07-22

88

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The PRéPaR project aims to construct, with the help of parents and early care providers, a support program for the families of infants at an increased risk for neurodevelopmental disorders, and to evaluate the acceptability and feasibility of such a program. This program aims to strengthen parenting skills, support infant development and improve the continuity of hospital/non-hospital care, including early identification of neurodevelopmental motor disorders and continuation of the support initiated during neonatal hospitalization.

CONDITIONS

Official Title

Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For WP1 parents of children with neurodevelopmental difficulties, the child must be 18 to 48 months corrected age.
  • Child must have at least one high neurodevelopmental risk factor at birth: preterm ≤ 31 weeks + 6 days, birth weight under 1500g, stroke or stage 2 or 3 hypoxic-ischaemic encephalopathy, or central neurological lesion.
  • Child must have an abnormal, non-transient clinical state such as diagnosed or in-progress cerebral palsy, central neurological syndrome, or neurodevelopmental disorder.
  • Parents must be able to participate in 3 interviews.
  • For WP1 infants at high neurodevelopmental risk at hospital discharge, child must be 34 weeks amenorrhea to 12 months corrected age.
  • Child must have at least one high neurodevelopmental risk factor at birth as above.
  • Parents must be able to participate in 3 interviews.
  • Professionals and parent support groups involved must have agreed to participate.
  • For WP2, parents of children hospitalized at CHU Dijon must be between 34 weeks amenorrhea and 3 months corrected age.
  • Child must have had a stroke or stage 2 or 3 hypoxic-ischaemic encephalopathy or central neurological lesion.
  • Professionals involved in care must have agreed to participate.
Not Eligible

You will not qualify if you...

  • Parents physically or cognitively unable to participate in group interviews or lacking sufficient French language skills.
  • Parents who are minors.
  • Parents under legal protection.
  • Parents of children with major orthopedic or traumatic disorders unrelated to cerebral palsy risk.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

S

Sandrine JANDET CARON

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization | DecenTrialz